ZG006 and ZG005 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma

Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study ID
NCT07038096
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • ZG006 — DRUG
    ZG006 will be administered as an intravenous (IV) infusion.
  • ZG005 — DRUG
    ZG005 will be administered as an intravenous (IV) infusion.

Study Details

This study is a randomized, multicenter, Phase Ib/II clinical trial, aimed at evaluating the efficacy and safety of the combination of ZG006 and ZG005 in patients with advanced small cell lung cancer and neuroendocrine carcinoma.

Key Dates

First listed
Jun 26, 2025
Start date
Sep 23, 2025
Status verified
Dec 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
350 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase Ib: Part1-Dose Escalation
    This study will employ the traditional "3+3" dose escalation design. Ultimately, two combination dosing cohorts will be selected to enter Part 2, the dose expansion phase, based on a comprehensive evaluation of the safety and pharmacokinetic (PK) data obtained by the investigators and the sponsor.
  • Experimental: Phase Ib: Part2-Dose Expansion
    The safety and pharmacokinetic (PK) data obtained in Part 1 will be used to determine two expansion phase doses of the ZG006 and ZG005 combination. The dose expansion study will further evaluate the efficacy of the two selected combination dosing cohorts in patients with advanced small cell lung cancer and neuroendocrine carcinoma.
  • Experimental: Phase II
    Participants will receive the RP2D of ZG006 in combination with ZG005 identified in Phase Ib of the study.

Primary Outcome Measure

Number of Participants Who Experienced Dose-limiting Toxicity (DLT) [ Time Frame: up to 28 days ]

Central Contacts

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